Intermittent Preventive Treatment in Infant in Mali

Sponsor

University of Bamako (Other)

Overall Status

Completed

CT.gov ID

NCT00766662

Collaborator

UNICEF (Other)

Location

Duration (Months)

Study Details

Study Description

Brief Summary

Studies have shown that Intermittent preventive treatment in infants (IPTi) with Sulfadoxine-pyrimethamine (SP)reduced the incidence of clinical malaria and anemia without modifying infants' serological response to EPI vaccines. Thus IPTi was seen as a potential public health tool of great benefit to the children of Africa and a logical addition to the Immunization Plus package. The objectives of this operational researcher were

to develop an implementation model for IPTi in the health care system in Mali
to assess its impact on the EPI vaccines and other health interventions coverage
and on molecular makers of resistance to SP

Condition or Disease	Intervention/Treatment	Phase
Malaria	Drug: Sulfadoxine pyrimethamine	N/A

Detailed Description

The study was implemented in districts of the region of Koulikoro; the district of Koulikoro and the district of Kolokani. The whole district of Koulikoro was covered by the intervention while in Kolokani, the 22 health areas (sub districts) were randomized in 1:1 ratio with the intervention in 11 health areas and the other 11 serving as control for the assessment of the impact of IPTi implementation on EPI vaccines and other health interventions coverage as well as its impact on the resistance to SP. The implementation consisted of administration of ½ tablet of Sulfadoxine -Pyrimethamine with EPI vaccines (DTP2, DTP3 and Measles vaccine) from December 2006 to December 2007.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Health Services Research

Study Start Date :

Oct 1, 2006

Actual Primary Completion Date :

Dec 1, 2007

Actual Study Completion Date :

Dec 1, 2007

Outcome Measures

Primary Outcome Measures

EPI vaccines and other health interventions coverage [1 year]
Molecular makers of resistance of P. falciparum to Sulfaxodine- pyrimethamine [1 year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 23 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Resident of Kolokani, Mali
Age less than 24 months

Exclusion Criteria:

Not Resident of Kolokani
Age of 24 months or above

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Malaria Research & Training Center; Faculty of Medicine, Pharmacy and Dentistry, University of Bamako	Bamako		Mali	0000

Sponsors and Collaborators

University of Bamako
UNICEF

Investigators

Principal Investigator: Alassane Dicko, MD, Faculty of Medicine, Pharmacy and Dentistry; University of Bamako
Study Director: Ogobara K Doumbo, MD, Faculty of Medicine, Pharmacy and Dentistry; University of Bamako